Description of Event or Problem · 0
ON MAY 08, 2024, A CORRESPONDENCE WAS RECEIVED VIA EMAIL CONCERNING AN ADVERSE EVENT THAT WAS REPORTED FOR A PRODUCT THAT NEPHRON MARKETS. THE SAFETY INCIDENCE WAS REPORTED VIA THE MEDWATCH PROGRAM AND THE EMAIL CONTAINED A MEDWATCH LETTER AND ACCOMPANYING MEDICAL DEVICE REPORT FOR NEPHRON'S AWARENESS. THE REPORT INVOLVES A PATIENT WHO PRESENTED TO THE EMERGENCY DEPARTMENT ON (B)(6) WITH ACUTE ON CHRONIC RESPIRATORY FAILURE WITH HYPOXIA AND HYPERCAPNIA. THE PATIENT WAS ADMITTED ON BROAD SPECTRUM ANTIBIOTICS, STEROIDS, AND SCHEDULED NEBULIZERS. ON (B)(6) AT 2028, THE PATIENT RECEIVED 4 ML OF 7% SODIUM CHLORIDE SOLUTION FOR INHALATION. SHORTLY AFTER ADMINISTRATION, THE RESPIRATORY THERAPIST REPORTED THE PATIENT WAS "UNABLE TO BREATHE" WITH OXYGEN SATURATIONS DOWN TO 40% AND A HEART RATE IN THE 140S. THE PATIENT WAS THEN INTUBATED AND TRANSFERRED TO THE ICU (INTENSIVE CARE UNIT). THE MEDICATION WAS NOT USED AGAIN, AND THE PATIENT WAS EXTUBATED ~1000 ON (B)(6). COPD (CHRONIC OBSTRUCTIVE PULMONARY DISEASE)/ ASTHMA WITH ACUTE EXACERBATION, PNEUMONIA. SIGNIFICANT PRIOR TO ADMISSION MEDICATIONS INCLUDE FUROSEMIDE, METOPROLOL, MIRTAZAPINE, ALBUTEROL, AS NEEDED OXYCODONE, AND TRELEGY ELLIPTA. THE PATIENT HAD NO SIGNIFICANT ALLERGIES AT THE TIME OF ADMISSION.